Clinical Trials

Clinical trials are research studies that test how well new medical approaches work in people. Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.

Every clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has its own rules about who can participate. Some studies need volunteers with a certain disease. Some need healthy people. Others want just men or just women.

In the United States, an independent committee of physicians, statisticians and members of the community must approve and monitor the protocol. They make sure that that the risks are small and are worth the potential benefits.

National Institutes of Health

Clinical Trial on Wikipedia

In medicine, a '''clinical trial''' (synonyms: clinical studies, research protocols, medical research) is a research study.

Types of clinical trial

The most commonly performed clinical trials evaluate new drugs or medical therapies to patients in strictly scientifically controlled settings. The purpose of such trials is to determine whether one or more treatment options are safe, effective, and better than current standard care. They are designed to be ethical, they must involve the full and informed consent of participating human subjects and they are closely supervised by the appropriate authorities. They usually must be approved by an ethics committee before permission is granted to run the trial. The study design that provides the most compelling evidence of a causual relationship between the treatment and the effect, is the '''randomized controlled trial'''. Other forms of clinical studies such as the cohort study and the case-control study are still useful but provide less compelling evidence than the randomized controlled trial. Currently most drug trials are designed to be randomized, double-blind, and placebo-controlled. This means that each study subject is randomly assigned to receive one of the treatments, which might be the placebo. Neither the subjects nor scientists involved in the study know which study treatment is being administered to any given subject; and, in particular, none of those involved in the study know which subjects are being administered a placebo. Most clinical trials require large numbers of participants and sometimes it is necessary to organize '''multicentre''' clinical trials. Often the centres taking part in such trials are in different countries (in which case they are termed '''international clinical trials'''). The number of patients enrolled in the study also has a large bearing on the study-power of the trial. The larger the sample size, the greater the study-power. However, in designing ... [ Read More ]

External Resources

Cure Your Asthma in Just 1 Week - Personal account of a natural treatment for asthma, sinus and allergies that has been proven to work by clinical trials.

Biostatistics in Clinical Trials - Covers a range of topics that relate to design, conduct, and analysis of clinical trials. Articles discuss biostatistical aspects of clinical trials from societies to collaborative trial groups. Part of the Wiley Reference Series In Biostatistics.

Maca Source - Concentrated source of gelatinized maca. Includes product comparisons and clinical trial data.

Hawaiian Health Products - Herbal formulas for cancer assistance and immune boosting, based on mushrooms. Includes clinical trial information and research.

Alpha Tinnitus Formulas, Inc. - Tinnitus and Meniere's Disease information pages, details of clinical trials, and capsules.

Migraine Manager - A cool air device that soothes migraine and headache pain. Highlighting clinical trial data and how the device works.

Optobionics - Silicon Retina - Artificial silicon retina for restoring vision in humans --- in clinical trials.

MediRent BV - MediRent specializes in support services for central laboratories, central research organizations (CRO's) and pharmaceutical companies with respect to clinical trials.

Protein Design Labs, Inc. - Develops humanized monoclonals to prevent and treat autoimmune disease, inflammatory conditions, cancers and viral infections. Includes clinical trials in Europe, manufactuing in Minnesota, headquartered in Fremont, California. (Nasdaq: PDLI)

Goodwin Biotechnology, Inc. - Manufacturer of monoclonal antibodies and recombinant proteins for preclinical and Phase I/II clinical trials, with cGMP facilities in Plantation, Florida.

Clinical Trials

Clinical Trial on Wikipedia

Types of clinical trial

External Resources

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